hot topics - fficm preparation course 230215
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Amato Study● Post hoc review of 9 RCTs
● Multilevel Mediation Analysis
● Functional Lung Size
● ΔP = (Pplt – PEEP) = (Vt /CRS
)
● Vt / Pplat / PEEP →ΔP
● ΔP 7 cmH20 = ↑41% mortality
● Requires validation
PROPPR● Pragmatic multicentre RCT
● 680 severely ill trauma patients
● 1:1:1 with 1:1:2 FFP / Plt / RC
● ↔ mortality:
● Day 1
● Day 30
● Reduced exsanguination deaths
● 1:1:2 group “caught up”
Chlorhexidine Bathing● Pragmatic, Cluster Randomized
Crossover study
● 9340 patients
● Once daily 2% chlorhexidine
● 2 x 10 week periods each
● ↔ in infections
● 55 vs 60
● 2.86 vs 2.90 / 1000 pt days
ALBIOS● Multicentre Open Label RCT
● 1795 patients with sepsis / shock
● 20% albumin + crystal vs crystal
● Target serum albumin > 30g/l
● ↔ 28 day mortality
● Albumin: 31.8% vs 32%
● ↔90 day mortality
● Albumin: 41.1% vs 43.6%
ARISE ● Australian / NZ RCT
● EGDT vs Usual Care
● Rivers algorithm
● 1600 patients with septic shock
● ↔90 mortality
● EGDT 18.6% vs 18.8%
● EGDT - more fluids,
vasopressors, RC, dobutamine
ProCESS● American multicentre RCT
● Testing Rivers EGDT protocol
● EDGT vs Standard vs Usual care
● 1341 patients with septic shock
● ↔ day 60 mortality
● 21% vs 18.2% vs 18.9%
● ↔ day 90 or 1 year mortality
CALORIES ● Pragmatic, open label RCT
● Enteral vs Parenteral nutrition
● Could be fed by either route
● 2400 emergency ICU pts
● ↔ Day 30 mortality
● PN: 33.1% vs EN: 34.2%
● PN – less hypos or vomiting
- no effect on infection
CIRC ● Mechanical CPR vs Manual CPR
● USA / European - OOHCA
● 4753 randomized, 522 excluded
● ↔ROSC: 28.6% v 32.3%
● ↔24 hour survival: 21.8% v 25%
● ↔ Hosp discharge: 9.4% vs 11%
LINC ● European open label RCT
● Mechanical CPR & defibrillation
● 2589 OOHCA patients
● ↔ 4 hr survival: 23.6% vs 23.7%
● ↔ CPC 1-2 survival
● At ICU / Hospital discharge
● At 1 or 6 month
HARP-2 ● Multicentre, UK/Ireland RCT
● Simvastatin vs Placebo
● 540 patients with ARDS
● ↔ Ventilator-free days
● ↔ Non-pulmonary organ
failure -free days
● ↔28 day mortality
METAPLUS ● European multi-centre RCT
● 301 pts expected ventilated >3/7
● Immune enhancing nutrients
● High protein diet both groups
● ↔new infections (53% vs 52%)
● ↑ 6/12 mortality with IMN
● 54% vs 35%
PEITHO ● European Multi-centre RCT
● 1,006 pts intermediate risk PE
● Tenecteplase & heparin vs
placebo & heparin
● ↓ Death / CVS decompensation
2.6% vs 5.6%
● ↔Deaths: 1.2% vs 1.8%; P=0.42
● ↑Stroke: 2.4% v 0.2%; ↑ Bleeding
SEPSISPAM● Multi-centre open label RCT
● 776 pts with septic shock
● MAP 80 - 85 vs 65 – 70
● ↔D28 mortality 36.6% vs 34%
● ↔D90 mortality 43.8% vs 42.3%
● ↔ serious adverse event
● ↑ AF with higher BP
● ↑ RRT with lower BP chronic HTN
TRISS● European multi-centre RCT
● 1005 pts septic shock & anaemia
● Transfuse Hb <9 g/dl vs <7 g/dl
● Less blood given (median 4 vs 1)
● ↔D90 mortality (45% vs 43%)
● ↔ischaemia / adverse events
VITdAL-ICU● Austrian single centre RCT
● 492 white ICU pts Vit D deficient
● Vit D vs Placebo
● ↔Hosp LOS 20 vs 19 days
● ↔ Hosp / 6/12 mortality
● Severely deficient subgroup
● ↓Hosp mortality 28% vs 46%
● ↔ Hosp / 6/12 mo
TTM Study● Multi-centre RCT
● 950 OOHCA Patients
● 33°C vs 36°C
● ↔All cause mortality
● 50% vs 48%
● ↔Poor neuro function
● 54% vs 52%
Kim Study● Prehospital cooling
● 1,359 OOHCA patients
● ↔ Survival to hosp discharge● VF 63% vs 64%
● nonVF 19% vs 16%
● ↔ Good neuro recovery● VF 57% vs 62%
● nonVF 14% vs 13%
CATIS Study● 4,071 patients
● Within 48 hrs ischemic stroke
● Nonthrombolysed and ↑SBP
● ↑ BP Rx vs no BP Rx
● BP control effective
● ↔ death and major disability
• 14 days / hosp discharge
• 3 months
INTERACT2● Early ICH & ↑SBP
● SBP <140 mmHg vs <180
● 2,839 pts
● Aggressive BP control lead to
● Trend for adverse events
● ↓modified Rankin scores
● ↔mortality
CRISTAL ● Stratified, open label RCT
● Any colloid vs any crystalloid
● 2857 pts with hypovolaemic shock
● ↔ 28 day mortality
● 25.4% vs 27%
● Less deaths with colloids at D90
● 30.7% vs 34.2%
● Less vasopressors / ventilation
TracMan
● 909 intubated patients
● Tracheostomy timing
● ≤ 4 days vs > 10 days
● ↔Mortality / ICU LOS
● ↔Complications
● Only 45% late group received trache
β Blockade in Septic Shock
● 154 septic pts with ↑HR & ↑dose NA
● Esmolol vs standard Rx
● Esmolol
● ↓ HR / lactate / Norad / Fluids
● ↑ SVI / LVSWI
● ↓ D28 mortality (49% vs 80%)
STATIN-VAP● 300 patients suspected VAP
● Simvastatin 60 mg vs placebo
● Study stopped early for futility
● ↔28 mortality
● ↔Duration MV
● ↔Δ SOFA
● ↑ mortality in statin naïve
● 21.5% vs 13.8%; p=0.054
VSE Study● 268 cardiac arrest pts● Adrenaline/Vasopressin/Methylpred
acutely & hydrocortisone later
● VSE associated with improved
● ROSC (84% vs 66%)
● Good neuro recovery
● 14% vs 5%
● 21% vs 8%
(post resuscitation shock)
PROSEVA
● 466 patients with severe ARDS
● Prone vs supine position
● Prone position associated with
● ↓ mortality D28: 16% vs 33%
● ↓ mortality D90: 24% vs 41%
● ↓ cardiac arrests
● ↔ complications
VILLANEAU• 921 pts with upper GI bleed
• Hb <7g/dL vs Hb<9g/dL transfusion
triggers
• Restrictive strategy:
• ↓ number of pts receiving
transfusion (15% vs 51%)
• ↑probability survival
• ↓ Less rebleeding / AEs
REDOXS● 1,223 pts with MOF
● Glutamine & antioxidants
● Glutamine:
● ↑ mortality
● D28 (34% vs 27%; p=0.05)
● D90 (44% vs 37%; p=0.02)
● Antioxidants ineffective
● ↔Mortality / Other endoints
OSCILLATE● 548 pts with moderate-to-severe
ARDS
● Trial terminated early
● ↑mortality 47% vs 35%
● HFOV associated with
● ↑ sedation requirements
● ↑ neuromuscular blockade
● ↑ vasopressor support
OSCAR● 795 pts with moderate-to-severe
ARDS
● ↔Mortality 41% vs 41%
● ↔Duration antimicrobials
● ↔Duration pharmacological
vasoactive support
● ↔ LOS ICU or Hospital
CRICS
● 452 ventilated pts
● Not monitoring gastric volume
•↔VAP (15.8% vs 16.7%)
•↔ ICU-acquired infections
•↔Duration MV / ICU
or Hospital LOS
• ↑calorific goal (OR 1.77)
SUNSET-ICU
● Single-centre, block, randomised trial
● Resident nighttime intensivist
● ↔ICU LOS
● ↔Mortality
● ↔Other endpoints
Early Parenteral Nutrition
● Early PN versus starvation
● 1,372 patients
● Standard group: 40 % unfed
● ↔ 60 day mortality
● ↔LOS – ICU or Hospital
● PN: ↓ duration ventilation
Reversal● Retrospective observational
● Looked at 10 years of NEJM
publications
● Medical reversals – current practice
inferior to a prior standard
● 146/363 studies
● 40%
EN vs EN & PN
● 305 critically ill patients
● Day 3 & received <60% calorific goal
● EN plus PN to achieve 100% calorific
target vs EN alone
● EN plus PN associated with
● ↑Calories: 28 vs 20 kcal/kg
● ↓ Infection: 27% vs 38%
Best TRIP● 324 pts severe TBI
● ICP guided vs clinical and imaging
guided management
● ↔ Composite of functional &
cognitive measures
● ↔ 6 month mortality (ICP
39% vs C&I: 41%)
● ↔ Length of stay
CARRESS● 188 pts with acute decompensated
heart failure
● Stepped pharmacological therapy vs
ultrafiltration
● UF: ↑complications
↑creatinine
● +20.3 vs −3.5 μmol
● ↔weight loss
● - 5.5±5.1 vs - 5.7±3.9 kg
SLEAP Study● 423 pts
● Protocolised sedation vs PS plus daily
sedation break
● ↔ Time to extubation
● ↔ ICU LOS / Hospital LOS
● ↔ Delirium / Unintended
extubations
● PS & DSB: ↑sedation / nursing
CHEST study● 7000 ICU pts
● Fluid resuscitation with
● 6% HES 130/0.4 vs 0.9% saline
● ↔Mortality (HES 18% vs 17%)
● ↔LOS – ICU / Hospital
● HES associated with increased
● ↑RRT (7% vs 5.8%; RR 1.21)
● ↑Pruritus / Rash / Liver failure
6S Study
● 804 severe sepsis pts
● Fluid resuscitation
● 130/0.4 HES vs Ringer's acetate
● HES associated with
● ↑ D90 death (51% vs 43%)
● ↑ RRT (22% vs 16%)
● ↑ bleeding (10 v 6%,p=0.09)
IABP-II Study
● 600 pts with acute MI
& cardiogenic shock
● IABP vs no IABP
● ↔D30 death (IABP 40 v 41%)
● ↔Time to CVS stabilisation
● ↔ICU LOS
● ↔Catecholamines therapy
PROWESS SHOCK Study
● 1,697 pts with septic shock
● ↔28 day mortality
● APC 26.4% vs 24.2%
● ↔90 day mortality
● 34.1% vs 32.7%
● No subgroup effect seen
MASH-2
● 1,204 pts within 4 days of
aneurysmal SAH
● MgSO4 (64 mmol/day) vs placebo
● ↔Functional outcome
● ↔90 day mortality
● MgSO4 26% vs 25%
PRODEX / MIDEX● MIDEX (n=500)
● Dexmedetomidine v Midaz
● Dexmedetomidine:
● ↓duration ventilation
● ↑patient interaction
● ↑hypotension / bradycardia
● ↔ time at target sedation
● ↔ ICU / Hosp LOS / death
PRODEX / MIDEX
● PRODEX (n=437)
● Dexmedetomidine v Propofol
● Dexmedetomidine:
● ↑patient interaction
● ↔time at target sedation
● ↔Duration ventilation
● ↔ICU / Hosp LOS // Death
Fever Control● 200 pts with septic shock requiring
vasopressors
● External cooling (36.5 to 37°C) vs not
● Cooling was associated with
● Early ↓ vasopressors
● ↑ ICU shock reversal
● ↓ 14 day mortality
EDEN• 1000 pts early ALI
• Initial trophic EN vs full EN
● Trophic feeding Δ -900 kcal/day
● ↔Ventilator free days
● ↔60 day mortality
● ↔Infectious complications
● Full EN: ↑ GI complications
LIFENOX
● 8,307 acutely ill medical patients with
graduated compression stockings
● subcutaneous enoxaparin (40 mg
daily) vs. placebo
● ↔D30 death (4.9% vs 4.8%)
● ↔Bleeding (0.4% versus 0.3%)
BALTI-2
• 326 pts with ARDS
• salbutamol (15 μg/kg/h) vs. placebo
• Trial stopped early for safety
• ↑Mortality 34% vs 23%
● Risk ratio 1.47
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